Archived Investigations
Cytokinetics, Incorporated (NasdaqGS: CYTK)
Cytokinetics and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.
On March 10, 2025, the Company disclosed that the U.S. Food and Drug Administration (“FDA”) had decided not to convene an advisory committee meeting to review the Company’s New Drug Application (“NDA”) for its aficamten product. Then, on May 6, 2025, the Company disclosed that it had held multiple pre-NDA meetings with the FDA discussing safety monitoring and risk mitigation but chose to submit the NDA without a Risk Evaluation and Mitigation Strategy, instead relying on labeling and voluntary education materials.
On this news, the price of Cytokinetics’ shares fell, closing at $33.04 per share on May 7, 2025.
The case is Seidman v. Cytokinetics, Incorporated, et al., No. 25-cv-07923.